Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbidity, Mortality, Treatment and Outcome Analysis

Periprosthetic Fractures Clinical Trial

— PIPPAS  

Official title:

Peri-Implant and Peri-Prosthetic Fractures: Epidemiology, Morbility, Mortality, Treatment and Functional Outcome Analysis. A Prospective Multi Center Observational Collaborative Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04663893
• Other study ID #: PI 20-2041
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2022
• Source: Hospital Clínico Universitario de Valladolid
• Contact: Adela Pereda-Manso
• Phone: +34983420000
• Email: aperedama[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study supports Spanish data collection and analysis on Periprosthetic and Peri-implant fractures of the upper and lower limb. Treatment and clinical management of this fractures are complex and goes along with complications. There will be more than 70 hospitals providing information. This study will provide evidence on which is the best treatment for every unique patient. This will help trauma surgeons and geriatricians to provide better treatments, to improve health care in our society, reducing mortality, morbidity, improving functional outcomes, and reducing costs, which in turn will be advances in trauma care.

Description:

There is no clinical evidence on which are the best treatment options for Periprosthetic and Peri-implant fractures of the upper and lower limb. This is a multi-center collaborative study seeking to obtain a big number of patients. Data collection includes previous health status and quality of life, which is the clinical management and treatment, as well as the outcome after one month, six months and one year. The investigators will be able to define risk factors and clinical attitudes, which influence on the patient outcome. And therefore, be able to establish treatment protocols and give management recommendations based on the observed clinical evidence to improve healing indexes, morbidity and mortality, function, grade of autonomy and quality of live. Main questions to be answered are: 1. which is the epidemiology of Periprosthetic and Peri-implant fractures and how are they treated in Spain, 2. Identify risk factors for complications and worse outcomes, 3. which is the morbidity and mortality, 4. influence of the fracture type and implants already placed on management and outcome, 5. influence of the treatment on patients' grade of independency, and 6. identified which are the risk factors for treatment failure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with the diagnose of Periprosthetic fracture of the shoulder, elbow, hip or knee. Or patients with the diagnose of Peri-implant fracture of the scapula, humerus, forearm, pelvis, femur, patella, tibia or fibula. Or patient presenting cut-out or cut-in after DHS or nail after a proximal humeral fracture.
• 18 years or older

Exclusion Criteria:

• Spine PP or PI fracture
• PP or PI secondary to metastasis or tumoral fracture
• PP or PI intraoperative fracture
• PP or PI pathologic fracture
• PP ankle fracture
• PP or PI wrist or hand fracture
• Fixation failure without any new fracture line: except cut-out or cut-in after DHS or nail of a proximal humeral fracture.
• Pregnancy

Related Conditions & MeSH terms

• Fractures, Bone
• Peri-implant Fracture
• Peri-implant Fracture of the Upper or Lower Limb
• Periprosthetic Fracture of the Upper or Lower Limb
• Periprosthetic Fractures

Locations

Country	Name	City	State
Spain	Althaia, Xarxa Assistencial Universitària de Manresa	Barcelona
Spain	Hospital Clinic	Barcelona
Spain	Hospital Universitario Vall d´Hebrón	Barcelona
Spain	Mutua Universitaria de Tarrasa	Barcelona
Spain	Hospital de Jove	Gijón
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (70)

Lead Sponsor

Collaborator

Hospital Clínico Universitario de Valladolid

Althaia Xarxa Assistencial Universitària de Manresa, Complejo Hospitalario de Navarra, Complejo Hospitalario de Palencia, Complejo Hospitalario Llerena-Zafra, Badajoz, Complejo Hospitalario Universitario de Albacete, Complejo Hospitalario Universitario, A Coruña, Complexo Hospitalario Universitario de Pontevedra, Hospital Álvaro Cunqueiro, Hospital Can Misses, Ibiza, Hospital Carmen y Severo Ochoa de Cangas de Narcea, Asturias, Hospital Clinic of Barcelona, Hospital Clínico Universitario San Carlos, Madrid, Hospital Comarcal Alto Guadalquivir de Andújar, Jaén, Hospital Costa del Sol de Marbella, Málaga, Hospital de Basurto, Hospital de Jove, Gijón, Spain, Hospital de la Santa Creu i Sant Pau, Barcelona, Hospital Galdakao-Usansolo, Hospital General de Segovia, Hospital General Obispo Polanco, Teruel, Hospital General Universitario Reina Sofía, Murcia, Hospital Gral. Univ. Los Arcos del Mar Menor de Murcia, Hospital Gral. Univ. Morales Meseguer, Murcia, Hospital Gregorio Marañón, Madrid, Hospital Infanta Elena de Valdemoro, Madrid, Hospital Italiano de Buenos Aires, Argentina, Hospital Josep Trueta, Girona, Hospital Marqués de Valdecilla, Santander, Hospital Moisés Broggi de Sant Joan Despí, Barcelona, Hospital Mutua de Terrassa, Hospital Nuestra Señora de Sonsoles, Ávila, Hospital Parc De Salut Mar, Barcelona, Hospital Parc Taulí de Sabadell, Barcelona, Hospital Puerta de Hierro, Madrid, Hospital Reina Sofía de Tudela, Navarra, Hospital Royo Villanova - Ntra. Sra. de Gracia, Zaragoza, Hospital San Pedro, Logroño, Hospital Santa Bárbara, Soria, Hospital Santos Reyes de Aranda de Duero, Burgos, Hospital Sierrallana de Torrelavega, Cantabria, Hospital Son Llàtzer, Palma de Mallorca, Hospital Universitari Arnau de Vilanova, Lleida, Hospital Universitari Sagrat Cor, Barcelona, Hospital Universitario 12 de Octubre, Hospital Universitario de Álava - Txagorritxu, Alava, Hospital Universitario de Burgos, Hospital Universitario de Cabueñes, Asturias, Hospital Universitario de Canarias, Hospital Universitario de Donostia, Guipúzcoa, Hospital Universitario de Guadalajara, Hospital Universitario de León, Hospital Universitario Doctor Peset, Hospital Universitario Dr. Negrín, Gran Canaria, Hospital Universitario El Escorial, Madrid, Hospital Universitario Fundación Alcorcón, Madrid, Hospital Universitario Fundación Jiménez Díaz, Madrid, Hospital Universitario General de Elche, Elche, Hospital Universitario Infanta Leonor, Madrid, Hospital Universitario La Paz, Hospital Universitario Lucus Augusti, Lugo, Hospital Universitario Miguel Servet, Zaragoza, Hospital Universitario Pcpe. de Asturias de Alcalá de Henares, Madrid, Hospital Universitario Ramón y Cajal de Madrid, Hospital Universitario San Agustín de Avilés, Asturias, Hospital Universitario Virgen de la Macarena, Sevilla, Hospital Vall d'Hebron, Hospital Vega Baja de Orihuela, Alicante, Hospital Virgen de la Salud, Hospitales Universitarios Virgen del Rocío

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Rate of mortality at anytime from fracture diagnose up to 12 months	Up to 12 months
Primary	Fracture classification	Fracture classification using the UCS for periprosthetic fractures, and the adapted H. Broggi classification for peri-implant fractures. Number of patients in each classification group	Pre-operatively (Day -1)
Primary	Treatment	Number of patients treated with fixation or revision and fixation or implant removal	Post-operatively (Day +1)
Secondary	Fracture healing	Rate of bone union on X-rays	Up to 12 months
Secondary	Health related quality of life	EuroQuality of Life 5Dimensions 5Leves (EQ5D5L)	Up to 12 months
Secondary	Dependency	Clinical frailty scale (1-9) 1=very fit, 9=terminally ill	Up to 12 months
Secondary	Mental situation	Pfeiffer test	Up to 12 months
Secondary	Gait	FFN-MCD mobility scale (Fragility Fracture Network-Minimum Common Dataset). 1-5: 1=independent mobility, 5=No functional mobility	Up to 12 months
Secondary	Bone protector treatment	Is the patient under treatment with vitamine D, calcium, bone formation, bone modeling?	Up to 12 months
Secondary	Life style change	Need to change place of living because of the fracture or its sequels.	Up to 12 months
Secondary	Medical or Surgical complications	in need of at least one in-hospital night.	Up to 12 months